Medical Device Manufacturer · US , Medina , NY

Sigma Intl. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1994

Recent clearances: SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sigma Intl. General Hospital ✕

3 devices

1-3 of 3

Cleared Aug 26, 2004

SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY

General Hospital · 20d

Cleared Oct 07, 1996

SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV....

General Hospital · 87d

Cleared Oct 20, 1994

SIGMA 8000 AND SIGMA 8002

General Hospital · 169d